Mes compétences :
Audit
Business
Business development
Pharmaceutical Industry
Quality
Quality Audit
Teamwork
Entreprises
MYLAN
- Global Quality Auditor
SAINT PRIEST Cedex2010 - maintenantGlobal Quality Auditor for MYLAN, located in Lyon (FRANCE). Perform objective audits of internal GXP systems and external businesses for Mylan management in order to accurately depict the status of compliance and to foster improvements based on current GXP references and interpretations. Prepare all associated documentation including audit plans and audit reports. Provide guidance and support in the development of corrective actions based on GXP principles and current industry standards. Track and monitor audit responses and the implementation of corrective actions.
MERCK
- Raw Material Project Leader
Lyon2003 - 2009API Officer, Department “Regulatory & Development” in MYLAN France (formerly MERCK GENERIQUES France) (LYON 69). Technical, Regulatory follow-up and Sourcing of a range of 180 different active ingredients integrated in the formula of the MYLAN medicinal products. Assessment of DMF and analytical expertise, development follow-up of new synthesis processes for the pharmaceutical active substances: follow-up of the analytical and regulatory accreditations of the new sources; regulatory monitoring of the registered active ingredients. Audit of ASM following GMP rules and ICH-Q7. From June 2008, attached to Pharmaceutical development of the Business Unit Hospital Product.
CEVA Santé Animale
- R&D trainee
2002 - 2002R&D: CEVA SANTE Animale (LIBOURNE 33). Engaged in the pharmaceutical development of an anti-infective agent (part IIB to IIF). Industrial process optimization of FP, monitoring of stability tests. Optimization and validation of the analytical test procedures (Active Ingredient and impurities).
CREAPHARM
- R&D trainee
LE HAILLAN2001 - 2001University of Bordeaux 33. Multi-ingredients UV spectroscopy: Development and validation of the analytical method for the monitoring of dissolution tablets. HPLC, GC: CREAPHARM (BORDEAUX 33). Development and validation of HPLC, GC methods for the release of finished dosage forms.
E.N.S.C.T
- Chemistry trainee
1998 - 1998E.N.S.C.T agro-industrial chemistry Laboratory (TOULOUSE 31). Work carried out for the development of a new process of chlorination (monitoring of kinetic and racemic reactions).
Formations
Faculty Of Pharmacy (Bordeaux)
Bordeaux2002 - 2002DESS: Analytical methodologies applied to the Health medicinal products.
Master Degree
Le Havre University (Le Havre)
Le Havre2000 - 2001Master of Sciences & Technologies - Optional field: organic synthesis and structure-activity relationship.